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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by AstraZeneca to the U.S. FDA. Original Data : FDA Website

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    ACYCLOVIR USP, BULK

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    ALBUTEROL SULFATE PRESSURISED INHAL...

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    PEARL THERAPEUTICS IN...
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    31995
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    2017-10-06
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    ATENOLOL

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    ASTRAZENECA PHARMACEU...
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    6905
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    1987-03-30
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    ATENOLOL ACETATE

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    ASTRAZENECA PHARMACEU...
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    7101
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    1987-08-06
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    ATENOLOL BULK DRUG

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    IPR PHARMACEUTICALS I...
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    12149
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    1996-10-07
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    BUDESONIDE

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    ASTRAZENECA PHARMACEU...
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    33171
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    2018-10-10
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    CHLORHEXIDINE GLUCONATE 20% SOLUTIO...

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    ZENECA PHARMACEUTICAL...
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    3003
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    1977-08-12
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    DIPRIVAN

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    ZENECA PHARMACEUTICAL...
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    8915
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    1991-01-04
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    EXENDIN-4 INJECTION DRUG PRODUCT

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    AMYLIN PHARMACEUTICAL...
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    13157
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    1998-08-27
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    FOSCARNET SODIUM INTRAVENOUS SOLUTI...

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    ASTRA CLINICAL RESEAR...
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    6036
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    1985-10-02
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    GOSERELIN ACETATE

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    ASTRAZENECA PHARMACEU...
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    31488
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    2017-04-21
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    GOSERELIN ACETATE IMPLANT

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    ASTRAZENECA PHARMACEU...
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    31489
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    2017-04-21
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    HALOTHANE

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    ZENECA PHARMACEUTICAL...
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    10295
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    1993-06-17
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    LISINOPRIL BULK DRUG

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    ASTRAZENECA PHARMACEU...
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    10853
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    1994-04-08
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    LISINOPRIL DIHYDRATE

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    ZENECA PHARMACEUTICAL...
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    7141
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    1987-09-14
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    METOPROLOL SUCCINATE EXTENDED RELEA...

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    ASTRAZENECA PHARMACEU...
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    31140
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    2016-12-05
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    METOPROLOL SUCCINATE EXTENDED RELEA...

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    ASTRAZENECA PHARMACEU...
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    28206
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    2014-05-21
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    OMEPRAZOLE CAPSULES

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    ASTRA RESEARCH LABORA...
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    4863
    N/A
    1983-03-31
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    OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE

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    ASTRAZENECA AB
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    12726
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    1997-10-31
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    PRILOSEC MUPS TABLETS (OMEPRAZOLE M...

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    ASTRAZENECA AB
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    12694
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    1997-10-09
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    SDM-70 NITROGLYCERIN/POLYMER MIXTUR...

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    ZENECA INC
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    10066
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    1993-02-01
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    TCV-116

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    ASTRA MERCK INC
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    11487
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    1995-05-01
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    TERBUTALINE SULPHATE

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    ASTRA PHARMACEUTICAL ...
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    7942
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    1989-03-01
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    TOCAINIDE HCL. INJECTION

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    ASTRA USA INC
    Inactive
    5629
    N/A
    1984-12-14
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    ZESTRIL (LISINOPRIL) TABLETS

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    ZENECA PHARMACEUTICAL...
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    6911
    N/A
    1987-04-08
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    AZD2292

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    ASTRAZENECA PHARMACEU...
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    37547
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    2022-10-21
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    COSMOCIL CQ (POLYHEXAMETHYLENE BIGU...

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    ZENECA INC
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    6659
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    1986-10-28
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    FACILITIES AND CONTROLS AT THE WEST...

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    ASTRA USA INC
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    3923
    N/A
    1980-08-18
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    HUMANIZED MONOCLONAL ANTIBODY (HULM...

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    MEDIMMUNE INC
    Inactive
    18645
    N/A
    1996-12-23
    II
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    HUMANIZED MONOCLONAL ANTIBODY (MEDI...

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    MEDIMMUNE LLC
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    18671
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    2001-03-13
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    LEUKOTRIENES

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    ZENECA PHARMACEUTICAL...
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    4347
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    1981-12-03
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    MANUFACTURING SITE, FACILITIES, PER...

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    AB ASTRA
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    4945
    N/A
    1983-04-28
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    MANUFACTURING SITE, FACILITIES, PER...

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    AB ASTRA
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    5345
    N/A
    1984-05-03
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    AB ASTRA
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    4952
    N/A
    1983-04-28
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    POLYOXYETHYLENE FAT. ACID ESTERS

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    ZENECA PHARMACEUTICAL...
    Inactive
    4039
    N/A
    1980-04-22
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    SDM 70

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    ZENECA INC
    Inactive
    8099
    N/A
    1989-06-13
    II
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    SIPLIZUMAB [HUMANIZED MONOCLONAL AN...

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    MEDIMMUNE INC
    Inactive
    18647
    N/A
    1997-03-27
    II
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